Gastric Fistula
Conditions
Keywords
gastric fistula, perforation, endoscopy, closure, endolumenal
Brief summary
Background: T-shaped tissue anchors have promise to close incisions and perforations of the intestines securely. The closure of perforations, gastro-gastric, or intestinal fistulas usually requires invasive open or laparoscopic surgery under general anesthesia and can be complex surgeries due to their reoperative or inflammatory nature. Objective: The proposed use of full thickness tissue anchors adds a new surgical aspect to the endoscopic treatment of fistulas and perforations by offering a robust suture like closure of defects. Instead of a 20 cm abdominal incision or 3 or 4 one centimeter incisions with the related postoperative morbidity an endoscopic technique is used which requires no postoperative limitation of activities. Methods: In this study the investigators propose to use an endoscopic technique that eliminates the need for open or laparoscopic surgery and provides a more robust endoscopic repair than is possible with traditional endoscopic tools. Patients who are scheduled to undergo surgery for intestinal fistulas will be screened for study eligibility. Patients who are scheduled to undergo complex polypectomy, or submucosal dissection will be screened for study eligibility and informed about all possible therapies in case of an iatrogenic perforation (open - laparoscopic surgery, endoscopic clipping, endoscopic closure with tissue anchors). A commercially available flexible endoscope will be inserted through the mouth and the fistula or perforation will be closed using the Tissue Approximation System (Ethicon Endo Surgery, Cincinnati, OH). The investigators will initially evaluate the potential benefit, risks and impact on the patient's quality of life of this modified surgical technique in 5 patients. Expected results: The potential advantages to the patients entered into this study result from the avoidance of open or laparoscopic surgery with the related risks (bleeding, injury of organs, post operative wound infection, hernia), shorter hospital stay, reduced postoperative pain, earlier return to work, and cosmetic advantage.
Interventions
PROCEDUREgastro-gastric fistula closure
The mucosa surrounding the orifice of the fistula will be ablated using standard endoscopic techniques. Remnants of mucosa will be treated with argon-plasma coagulation. The mucosa free orifice of the fistula will be closed using the Tissue Apposition System. Tissue anchors with attached threads will be deployed through the intestinal wall full thickness using delivery needles through the working channel of the endoscope. After two anchors are deployed on both sides of the fistulas' orifice a knotting element will be cinched down to approximate the two sides of the fistulas' orifice. The procedure will be repeated until the fistulas' orifice is securely closed.
Sponsors
Ethicon Endo-Surgery
Legacy Health System
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Ability to undergo general anesthesia * Age \> 18 yrs. of age and \< 85 yrs. of age * Ability to give informed consent
Exclusion criteria
* Contraindicated for esophagogastroduodenoscopy (EGD) * Contraindicated for colonoscopy * BMI \< 40 * Presence of esophageal stricture * Altered gastric anatomy * Intraabdominal abscess or severe inflammation * Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| fistula or perforation closure possible; yes or no | day of surgery |
Secondary
| Measure | Time frame |
|---|---|
| fistula stays closed after 6 months | 6 months |
| quality of life comparison, pre-op and after 6 months post-op | 6 months |
Countries
United States
Outcome results
None listed